Hand over your Humira biosim launch plans, judge tells Boehringer in AbbVie patent fight

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A judge ordered Boehringer to hand over its launch plans for Cytelzo, its Humira biosimilar, in a patent fight with AbbVie. (Pixabay)

AbbVie and Boehringer Ingelheim are locked in a high-stakes patent dispute over the world’s bestselling drug—even after other biosim makers have agreed to put off their launches till 2023. Just when is BI planning to roll its version? AbbVie wants to know—and it persuaded the trial judge to force Boehringer to release its plans.

Judge Richard Lloret ruled that Boehringer must detail its debut plans for Cytelzo, which has won FDA approval but hasn’t yet hit the market.

In the patent case, Boehringer argues AbbVie has “unclean hands” when it comes to protecting Humira from competition. It's an idea that came under scrutiny Tuesday during the Senate Finance Committee's pricing hearing, where AbbVie CEO Richard Gonzalez faced questioning about Humira's plethora of patents.

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In its lawsuit, AbbVie claims Boehringer's biosim will infringe Humira's IP protections, but the German drugmaker says AbbVie acted inequitably by pursuing overlapping and noninventive patents, and that it used patent disputes and the courts as tools to delay competition. 

Boehringer has resisted sharing its launch plans as part of the lawsuit, but on Monday, Judge Lloret ruled the company must hand them over. 

“In short, if Boehringer argues—as it does—that the purpose and effect of the ‘patent thicket’ was to delay competition and damage competitors, and seeks to prove this purpose and effect, it cannot refuse to quantify the delay and the damage,” the judge wrote. “That would be unfair.” 

The ruling marks a win for AbbVie after a recent defeat, when the judge ordered the company to give up documents it had fought to keep secret. 

RELATED: AbbVie loses bid to hoard documents in Humira patent fight with Boehringer 

Humira is the world’s best-selling drug, generating nearly $20 billion last year, about two-thirds of that—$13.6 billion—in the U.S. The drug came into the spotlight during Tuesday’s hearing, when Gonzalez took questions on the company’s tax rate, Humira pricing and even his bonus.  

RELATED: Big Pharma grilled on the Hill: International pricing, AbbVie CEO's bonus and bye-bye rebates 

At the outset of the meeting, Sen. Ron Wyden, D-Ore., said AbbVie doubled Humira’s price in six years and that patients can’t opt for cheaper options because the company protects Humira’s exclusivity “like Gollum with his ring.” 

Humira already faces biosimilar competition in Europe, but thanks to agreements AbbVie has inked with several biosim developers, cheaper copies won’t hit the U.S. until 2023. At Tuesday’s hearing, Gonzalez said the deals might not be "popular," but he believes the company has struck a “reasonable balance” with patent settlements because early patents in the portfolio expire in 2022.

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